Healthcare Professionals

Durepair Regeneration Matrix

DURA MATER REPAIR

Durepair Dura Regeneration Matrix

Durepair™ Regeneration Matrix is a non-synthetic dura substitute used to repair defects in the dura.


WHAT IS DUREPAIR?

Cerebrospinal fluid (CSF) leaks during surgery often result in extra time in the operating room. A CSF leak after surgery may require re-operation – adding more time and cost to a patient’s care.1 In addition, products that are too delicate and difficult to handle can be time consuming and frustrating to work with.1 Durepair was manufactured to address these issues.

Durepair is a non-synthetic dura substitute for repair of the dura mater during neurosurgical procedures. It uses a patented technology to produce a strong yet flexible collagen matrix that can be applied as an onlay or suturable graft.2

Flexibility

  • Can be used as an onlay or suturable graft2
  • Conforms to the patient’s1-4 own dura2-3
  • Can be trimmed wet or dry
  • Graft adheres well to the native dura3

Strength

  • Collagen matrix creates a product that is strong yet pliable.2
  • Collagen matrix seals around suture holes to avoid CSF leakage.5
  • Porosity of material allows for tissue ingrowth.2

Convenience

  • Refrigeration not needed (2°–30° C/35°–86° F)1,4
  • Easy to handle and reposition when wet2
  • Easy to prepare for surgery — hydrates in 30–60 seconds1,4
  • Available in a variety of sizes for small leaks and large repairs

HOW DUREPAIR WORKS

Durepair Dura Regeneration Matrix consists of both Type I and Type III collagen. Durepair is unique in that it uses Type III fetal bovine tissue that has gone through an extensive patented process to remove the cellular components. This leaves undamaged pure collagen that acts as a neutral tissue.6 The entanglement of strong collagen cables form a highly porous matrix — typically 10–20 micron pores. This matrix is a scaffold for the ingrowth of fibroblasts and blood vessels.2

Important Safety Information

In addition to the risks associated with any brain surgical procedure, such as bleeding, damage to surrounding brain tissue, seizures, stroke, or death, the following complications may also occur: infections, cerebrospinal fluid (CSF) leaks, adhesions, hematomas, rejection/foreign body reaction, inflammatory reactions, and calcification. At times the common complications can provide serious risks and should be treated promptly as such. It is important to review the product labeling for complete safety information, potential complications, contraindications, and a complete explanation of warnings and precautions.

1

Medtronic Durepair™ Dura Regeneration Matrix, LIT59427C; 2011.

2

Zerris et al. J of Biomed Mat Rsch 2007; 83B(2):580-588 (Canine Study).

3

Pollay M. and Lentz L. “Short-Term Evaluation of Medtronic Durepair®, DuraGen Plus™, and Duraform™ as Only Dural Grafts.” White Paper, LIT59502A; 2006.

4

Durepair™ Manual; Document Number 15614COM-1 Rev. T.

5

Durepair Dura Regeneration Matrix Product Evaluation Protocol No. 0203 Commercial Release Report, 16 March 2004.

6

Medtronic 510(k) #K041000.